- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04913051
Interest of Day Hospital Care for Patients With Chronic Regional Pain Syndrome Referred to the Chronic Pain Unit for the First Time
Chronic Regional Pain Syndrome (CRPS) is a chronic disabling disease. Patients present a variable picture associating pain localized to an articular or peri-articular region, motor and vasomotor disorders and trophic disorders.
Its pathophysiology, still poorly understood to this day, results from local inflammatory phenomena complicated by peripheral sensitization and central spinal and cerebral sensitization.
The diagnosis is made difficult by the fluctuating nature of the symptoms and the absence of specific complementary examination.
The treatment of CRPS is symptomatic and requires multidisciplinary care. CRPS is responsible for an alteration in the patient's quality of life. This pathology has a global impact because it affects not only the biomedical sphere but also the socio-family, professional and psychological spheres.
The investigators hypothesize that multidisciplinary intervention in the Day Hospital would improve the quality of life of patients with CRPS. The investigators also think that the passage in Day Hospital would make it possible to improve the pains, the functionality of the affected limb as well as the satisfaction of the patients.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Le Mans, France, 72000
- Centre Hospitalier du Mans
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient volunteers over 18 years of age
- Diagnosis of CRPS according to the Budapest criteria
- Referred to pain assessment and treatment center
Exclusion Criteria:
- Patients unable to express their wishes or understand the protocol
- Diagnosis of CRPS not meeting Budapest criteria
- Patients previously seen at pain assessment and treatment center for the care of CRPS
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Evaluate impact of day hospital care on quality of life
Time Frame: 3 months after day hospital
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Impact of quality of life was assessed by questionnaire Short Form Health Survey (SF36).
A score ranging from 0 to 100 is obtained.
A low score reflects a perception of poor health, loss of function, presence of pain.
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3 months after day hospital
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Evaluate impact of day hospital care on quality of life
Time Frame: 6 months after day hospital
|
Impact of quality of life was assessed by questionnaire Short Form Health Survey (SF36).
A score ranging from 0 to 100 is obtained.
A low score reflects a perception of poor health, loss of function, presence of pain.
|
6 months after day hospital
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHM-2020/S44/15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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